Radiofrequency Ablation and Stabilization for Treating Metastatic Spine Tumors Confirmed by PET-CT

What this Trial Is About

Researchers are evaluating metabolic changes in spine lesions treated with a combination of augmentation and radiofrequency ablation RFA in patients with secondary vertebral bone tumors. This pilot study aims to demonstrate the effectiveness of a new percutaneous ablation device called Osteocool-Medtronic while avoiding bias from other treatments. The study focuses on patients with osteolytic or mixed lytic and sclerotic spine tumors that are metabolically active. Participants will receive treatment with percutaneous tumor ablation of spine lesions followed by polymer augmentation using the Osteocool-Medtronic device. Only patients with one to three active lesions identified by recent PET-CT scans will be included. After treatment, patients will undergo a follow-up PET-CT to assess the activity at the treated sites. During the study, patients will be informed and asked to consent before treatment. They will have PET-CT scans before and after the procedure to measure metabolic activity changes. The primary outcome is the PET-CT SUV measurement within 24 hours post-treatment. Secondary outcomes include assessments using the Greek Brief Pain Index at 1, 6, and 12 months. The study runs through the end of 2028 and involves monitoring patients lesion activity and pain levels over time.

Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By Positron Emission Computed Tomography (PET-CT) Confirmation